AnalgesiaNCT04049656
Confirmatory Study of HFVI Guided Analgesic Administration in Surgical Subjects
A study testing HFVI in people with Analgesia, run by University of Florida at 1 site in United States.
Trial summary
The current study is intended to be a prospective clinical performance validation study designed to confirm the clinical utility of HFVI-guided fentanyl administration during sevoflurane anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- HFVI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2020to 9 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to provide informed consent
- American Society of Anesthesiologist Physical Status 1 or 2
- Body Mass Index range of 19-35 kg.m-2.
- Planned spinal or open abdominal surgery expected to last 1-3 hours utilizing a balanced sevoflurane-fentanyl general anesthetic
Who cannot join
- Subjects are unable or unwilling to give informed consent.
- Emergency surgery
- Women who are currently pregnant or not using a medically acceptable means of birth control
- Cardiac morbidity, including non-regular sinus cardiac rhythm or implanted cardiac pacemaker
- Concurrent medications with a major effect upon the sinus node including prescribed antimuscarinic agents, α2-adrenergic agonists, β1-adrenergic antagonists, and antiarrhythmic agents
- Expected duration of surgery less than 1 hour (60 minutes) or greater than 3 hours (180 minutes)
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- Pre-operative chronic opioid use or chronic pain, equivalent to requiring oxycodone 20mg per oral, per day for more than 6 weeks
- Allergy or intolerance to any of the anticipated study medications, such as history of malignant hyperthermia during anesthesia
- Planned use of neuraxial anesthesia
- Clinically significant abnormality or clinically significant unstable medical condition, as indicated by medical history, physical examination, ECG results, or clinical laboratory testing, that in the Investigator's judgment might pose a potential safety risk to the subject or limit interpretation of the trial results, e.g., any uncontrolled thyroid disorders, hepatic, cardiac, pulmonary and renal malfunctioning.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, PACU Blinded, Clinical Utility Study to Confirm the Safety and Efficacy of HFVI-Guided Analgesic Administration in Surgical Subjects Receiving Balanced Sevoflurane-Fentanyl Anesthesia
The current study is intended to be a prospective clinical performance validation study designed to confirm the clinical utility of HFVI-guided fentanyl administration during sevoflurane anesthesia.
The overall objective of this study is to confirm the safety and efficacy of HFVI-guided analgesic administration in comparison to standard clinical practice. The primary efficacy endpoint will be the amount of postoperative pain reported in the PACU, as measured using a nurse administered Numerical Rating Scale (NRS) pain score.
Read the detailed description
HFVi was designed to provide a standardized measure of the parasympathetic component (p∑) of the Autonomous Nervous System (ANS). It tracts changes of the p∑ tonus induced by each respiratory cycle (spontaneous or artificial) to measure the relative balance of parasympathetic and sympathetic tone as reflected in the EKG signal.
These rapid changes of the p∑ tonus express themselves at the sinus node level by changes of the time interval separating two R waves of the electrocardiogram. The following normal RR intervals constitute the tachogram (displayed as respiratory pattern on the monitor). The p ∑ component is evaluated after filtering, standardization and re-sampling of the R-R series, by measuring the surface generated by respiratory cycles on the tachogram. Higher p∑ tonus is reflected as a larger measured surface area. In contrast, the measured surface decreases when the p∑ decreases.
HFVi, a measure of the surface area, is expressed in the form of a dimensionless index ranging from 0 to 100. This index reflects the relative activity of the parasympathetic nervous system. It expresses the relative quantity of the present p∑ tonus compared to the Para and sympathetic tonus. The measure of HFVi displayed represents the average of a sequence of measurements: each elementary measure is realized on 64 seconds of data, updated each second using a sliding window.
During development, a probabilistic interpretation of the HFVi was used to relate index values to a clinical state in an anesthetized subject. A significant hemodynamic response (increase of the heart rare or blood pressure of 20% compared to the baseline) within 10 minutes was used as an indicator of nociception/inadequate analgesia.
As a measure of parasympathetic tone, HFVi may be influenced by many factors and thus be difficult to interpret in many of the following situations:
- arrhythmia
- no breathing (ex : apnea due to intubation)
- Respiratory rate lower than 9 cycles/min
- Tidal volume variable on the measuring time, thus 64 seconds
- Irregular breathing (when the patient speaks, laugh or cough)
- pace maker (some types)
- heart transplantation
- Drug use having a significant effect on the sinus cardiac activity
- Conditions
- Analgesia
- Being tested
- HFVI
- Keywords
- Sevoflurane-Fentanyl Anesthesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFVIDevice
Subjects in the HFVI intervention group will be monitored in the same manner as the control group, but the HFVI monitor display will also be available to the anesthesia provider in real time. Bolus doses of 25ug or 50 ug of fentanyl will be recommended to be administered when the HFVI values begin to decrease below 50, and as needed based on the judgment of the clinician responsible for the case. All anesthetic medications that are given, patient events, and vital sign recordings will be included in the anesthetic record and data collection forms.
| Study group | Role | What they receive |
|---|---|---|
| HFVI intervention group | Experimental | Subjects in the HFVI intervention group will be monitored in the same manner as the control group, but the HFVI monitor display will also be available to the anesthesia provider in real time. Bolus doses of 25ug or 50 ug of fentanyl will be recommended to be administered when the HFVI values begin to decrease below 50, and as needed based on the judgment of the clinician responsible for the case. All anesthetic medications that are given, patient events, and vital sign recordings will be included in the anesthetic record and data collection forms. Receives: Device: HFVI |
| Standard of Care Group | No intervention | Subjects receiving a balanced maintenance anesthetic consisting primarily of a sevoflurane hypnotic (titrated to a BIS range of 40-60) and fentanyl analgesia. Subjects randomized to the control group (Standard Practice) will have analgesia administered as needed according to standard clinical monitoring and practice requirements based on the judgment of the clinician responsible for the case. The HFVI monitor will be applied, but the display will be masked in this control group population. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Numerical Pain Scores (NPS)
The change in numerical pain scores reported during the first hour (scores at 15, 30, 45, and 60 minutes) of recovery. The NPS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain, with 0 being 'no pain' and 10 being 'the worst pain.' Subjects and clinical pain assessors will remain blinded to treatment group assignment.
Measured: 15 minutes; 30 minutes; 45 minutes; 60 minutes
Secondary outcomes (3)
Percentage of patients minimal pain (NPS < 3) during recovery
The percent of subjects with minimal pain (NPS < 3) during recovery
Measured: Hour 1
Number of opioid analgesics administered in the operating room (OR) and post-anesthesia care unit (PACU).
The total amounts of opioid analgesics administered in the OR and PACU, respectively.
Measured: Hour 1
Incidence of postoperative nausea and vomiting (PONV) in the PACU
The incidence of significant PONV (emesis) during recovery in the PACU.
Measured: Hour 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start8 Oct 2020
- Primary completion9 Jan 2024
- Study completion9 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Prospective, Randomized, PACU Blinded, Clinical Utility Study to Confirm the Safety and Efficacy of HFVI-Guided Analgesic Administration in Surgical Subjects Receiving Balanced Sevoflurane-Fentanyl Anesthesia
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Mdoloris Medical Systems
- Responsible party
- Sponsor
- Investigators
- Jay W Johansen, MD, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049656
- Sponsor's protocol ID
- OCR27162
- Other IDs
- 20192697
- Status last verified
- Jul 2023
- First submitted
- 6 Aug 2019
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, PACU Blinded, Clinical Utility Study to Confirm the Safety and Efficacy of HFVI-Guided Analgesic Administration in Surgical Subjects Receiving Balanced Sevoflurane-Fentanyl Anesthesia
- ClinicalTrials.gov ID
- NCT04049656
- Acronym / sponsor ID
- OCR27162
- Conditions
- Analgesia
- Keywords
- Sevoflurane-Fentanyl Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Mdoloris Medical Systems
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 9 Jan 2024 (actual)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study is intended to be a prospective clinical performance validation study designed to confirm the clinical utility of HFVI-guided fentanyl administration during sevoflurane anesthesia.
The overall objective of this study is to confirm the safety and efficacy of HFVI-guided analgesic administration in comparison to standard clinical practice. The primary efficacy endpoint will be the amount of postoperative pain reported in the PACU, as measured using a nurse administered Numerical Rating Scale (NRS) pain score.
Detailed description
HFVi was designed to provide a standardized measure of the parasympathetic component (p∑) of the Autonomous Nervous System (ANS). It tracts changes of the p∑ tonus induced by each respiratory cycle (spontaneous or artificial) to measure the relative balance of parasympathetic and sympathetic tone as reflected in the EKG signal.
These rapid changes of the p∑ tonus express themselves at the sinus node level by changes of the time interval separating two R waves of the electrocardiogram. The following normal RR intervals constitute the tachogram (displayed as respiratory pattern on the monitor). The p ∑ component is evaluated after filtering, standardization and re-sampling of the R-R series, by measuring the surface generated by respiratory cycles on the tachogram. Higher p∑ tonus is reflected as a larger measured surface area. In contrast, the measured surface decreases when the p∑ decreases.
HFVi, a measure of the surface area, is expressed in the form of a dimensionless index ranging from 0 to 100. This index reflects the relative activity of the parasympathetic nervous system. It expresses the relative quantity of the present p∑ tonus compared to the Para and sympathetic tonus. The measure of HFVi displayed represents the average of a sequence of measurements: each elementary measure is realized on 64 seconds of data, updated each second using a sliding window.
During development, a probabilistic interpretation of the HFVi was used to relate index values to a clinical state in an anesthetized subject. A significant hemodynamic response (increase of the heart rare or blood pressure of 20% compared to the baseline) within 10 minutes was used as an indicator of nociception/inadequate analgesia.
As a measure of parasympathetic tone, HFVi may be influenced by many factors and thus be difficult to interpret in many of the following situations:
- arrhythmia
- no breathing (ex : apnea due to intubation)
- Respiratory rate lower than 9 cycles/min
- Tidal volume variable on the measuring time, thus 64 seconds
- Irregular breathing (when the patient speaks, laugh or cough)
- pace maker (some types)
- heart transplantation
- Drug use having a significant effect on the sinus cardiac activity
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A Prospective, Randomized, PACU Blinded, Clinical Utility Study to Confirm the Safety and Efficacy of HFVI-Guided Analgesic Administration in Surgical Subjects Receiving Balanced Sevoflurane-Fentanyl Anesthesia
| Arm | Type | Receives |
|---|---|---|
| HFVI intervention group | Experimental | Device: HFVISubjects in the HFVI intervention group will be monitored in the same manner as the control group, but the HFVI monitor display will also be available to the anesthesia provider in real time. Bolus doses of 25ug or 50 ug of fentanyl will be recommended to be administered when the HFVI values begin to decrease below 50, and as needed based on the judgment of the clinician responsible for the case. All anesthetic medications that are given, patient events, and vital sign recordings will be included in the anesthetic record and data collection forms. |
| Standard of Care Group | No intervention | –Subjects receiving a balanced maintenance anesthetic consisting primarily of a sevoflurane hypnotic (titrated to a BIS range of 40-60) and fentanyl analgesia. Subjects randomized to the control group (Standard Practice) will have analgesia administered as needed according to standard clinical monitoring and practice requirements based on the judgment of the clinician responsible for the case. The HFVI monitor will be applied, but the display will be masked in this control group population. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to provide informed consent
- American Society of Anesthesiologist Physical Status 1 or 2
- Body Mass Index range of 19-35 kg.m-2.
- Planned spinal or open abdominal surgery expected to last 1-3 hours utilizing a balanced sevoflurane-fentanyl general anesthetic
Key exclusion criteria (10 listed)
- Subjects are unable or unwilling to give informed consent.
- Emergency surgery
- Women who are currently pregnant or not using a medically acceptable means of birth control
- Cardiac morbidity, including non-regular sinus cardiac rhythm or implanted cardiac pacemaker
- Concurrent medications with a major effect upon the sinus node including prescribed antimuscarinic agents, α2-adrenergic agonists, β1-adrenergic antagonists, and antiarrhythmic agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HFVISubjects in the HFVI intervention group will be monitored in the same manner as the control group, but the HFVI monitor display will also be available to the anesthesia provider in real time. Bolus doses of 25ug or 50 ug of fentanyl will be recommended to be administered when the HFVI values begin to decrease below 50, and as needed based on the judgment of the clinician responsible for the case. All anesthetic medications that are given, patient events, and vital sign recordings will be included in the anesthetic record and data collection forms. | Device | HFVI intervention group |
Primary outcome
Change in Numerical Pain Scores (NPS)
Time frame: 15 minutes; 30 minutes; 45 minutes; 60 minutes
The change in numerical pain scores reported during the first hour (scores at 15, 30, 45, and 60 minutes) of recovery. The NPS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain, with 0 being 'no pain' and 10 being 'the worst pain.' Subjects and clinical pain assessors will remain blinded to treatment group assignment.
3 secondary outcomes
Percentage of patients minimal pain (NPS < 3) during recovery
Time frame: Hour 1
Number of opioid analgesics administered in the operating room (OR) and post-anesthesia care unit (PACU).
Time frame: Hour 1
Incidence of postoperative nausea and vomiting (PONV) in the PACU
Time frame: Hour 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay W Johansen, MD, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFVI in people with Analgesia, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Numerical Pain Scores (NPS) (time frame: 15 minutes; 30 minutes; 45 minutes; 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.